FDA refuses review of mRNA flu vaccine
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Moderna (MRNA) stock fell 0.3% Friday despite beating Q4 revenue estimates at $678M and posting narrower loss of $2.11/share after FDA rejected flu vaccine review.
Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna
Moderna claimed that the decision, issued by top vaccine regulator Vinay Prasad, was “inconsistent” with prior FDA communications and went against the regulator’s established guidance for flu shots.
Moderna Inc (NASDAQ:MRNA) has delivered a 37% gain year-to-date, dramatically outpacing the biotech sector’s 0.4% YTD return. In fact, Moderna has the 12th-best gains in the entire S&P 500 so far in 2026!
Moderna will continue to lead clinical development and manufacturing for mRNA-3927Moderna to receive up to $160 million
The biotech announced Tuesday evening that in a rare move, the Food and Drug Administration won’t review its application for a mRNA-based flu vaccine over concerns about the choice of vaccine tested against the experimental vaccine in Phase 3 clinical trials. Moderna described the FDA as “inconsistent” in its communications.
Moderna advances messenger RNA platform technologies Therapeutics pipeline spans vaccines and disease targets nasdaq index inclusion reflects biotech scale Moderna, Inc. (NASDAQ:MRNA) operates within the biotechnology sector and remains a recognized component of the broader nasdaq index,
Moderna (NasdaqGS:MRNA) is involved in an ongoing patent infringement case related to its COVID-19 vaccine, with a recent court ruling addressing claims from Arbutus Biopharma and Genevant. The company has appointed Dr.